Monoclonal B-cell Lymphocytosis Study
PURPOSE OF THE STUDY:
The purpose of the study is to test the investigational oral drug known as SNS-062, a new reversible Bruton’s tyrosine kinase (BTK) inhibitor. Because binding is different than ibrutinib and acalabrutinib, the hope is that it will be effective when the CLL has become resistant to those two drugs due to a change in the site where they bind. The study will look at the following:
- Safety
- Pharmacokinetics (how your body processes the drug)
- Pharmacodynamics (how the drug affects your body) and
- Antitumor activity
The patient population that will be studied are:
- Adults who have advanced chronic lymphocytic leukemia (CLL) that has become resistant and has progressed after two or more prior treatments, including treatment with a BTK inhibitor, such as ibrutinib or acalabrutinib.
SNS-062 is being developed based on experiments in the lab showing that SNS-062 had similar anti-cancer activity against BTK untreated and certain BTK resistant cells.
Investigational means that the drug has not been approved by the Food and Drug Administration (FDA) and that research doctors are trying to find out more about it. SNS-062 is still under investigation to determine:
- What dose is safe
- What the side effects are
- Whether or not it will help treat the kind of cancer you have.
For all patients that participate in the study, your study doctor will gather information on:
- Your previous medical history
- Medications you are currently taking
- Any other medical information.
Your study doctor will review all your previous medical history and current medications that you are taking and will determine if you meet the study requirements, specifically:
- Patients have to be 18 or older
- Patients must have relapsed or refractory CLL that has been treated with two or more prior treatment regimens.
- One of the prior therapies had to include a BTK inhibitor, such as ibrutinib or acalabrutinib.
- Lab tests, like blood chemistries and blood count parameters have to meet certain criteria that your doctor will assess.
- Certain medicines cannot be taken with SNS-062, so your doctor will check to make sure you are not taking a drug that might increase the risk of side effects from the study medicine.
The study consists of two phases. If you meet the study requirements and you choose to participate, you will be one of approximately 48 patients in this first portion of the study.
The first phase (Phase 1b) is a “Dose Escalation phase”, which means that doses are tested and evaluated; increasing in strength to each group or cohort of patients over time. The purpose is to identify the dosage that will be tested in later phases. This part of the trial is currently open and enrolling patients.
Once the dosage is determined in the Phase 1b phase, the safety and activity of the drug will be studied in the Phase 2 phase. This dose will be given to a larger group of patients with previously treated CLL so that we can continue to study its safety profile and to evaluate its antitumor activity or effectiveness in fighting against your CLL.
The trial is being conducted at 5 sites in the United States; including:
- University of California, Irvine, Orange, CA
- MD Anderson Cancer Center, Houston, TX
- Weill-Cornell University, New York, NY
- Dana Farber Cancer Institute, Boston, MA
- The Ohio State University, Columbus, OH
The official title of the clinical trial is:
A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton’s Tyrosine Kinase Inhibitor, SNS-062, in Patients With B-Lymphoid Malignancies
More information can be obtained at https://clinicaltrials.gov/ct2/show/NCT03037645?term=sns-062&rank=1.
If you would like to talk to someone about participating in this trial, please reach out to
Meisa Propst
650-266-3765
Disclaimer: Please carefully review this or any clinical trial or therapy decision with your treatment team. The CLL Society wants you to be informed of all your treatment options but does not endorse any particular trial or therapy, including this one.
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